Viability of selected microorganisms in parenteral preparations for novel systemic anti-cancer therapy.

Background: Risk factors for aseptic preparation of parenteral medicines encompass the growth-promoting nature of the preparation. Although many aqueous parenteral preparations do not have growth-promoting properties, inadvertently introduced microorganisms may remain viable. Knowledge about the viability of microorganisms in parenteral preparations can add useful information for assigning shelf life to preparations used to treat cancer patients.

Physicochemical stability of ready-to-administer mitomycin C solutions for intravesical instillation.

Objective: The aim of the study was to investigate the physicochemical stability of mitomycin-containing medicinal products for bladder instillation, formulated with urea as excipient (mito-medac®, Mitomycin medac). For comparison, the stability of reconstituted Urocin® and Mitem® bladder instillation was studied.

Methods: Mitomycin-containing medicinal products were either reconstituted with the prepackaged 0.